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Covid-19: #UK extends lateral flow #test authorisation despite #US warning not to use them

BMJ 2021; 373 doi: doi.org/10.1136/bmj.n1… (Published 18 J
The UK medicines regulator has extended the authorisation for the lateral flow tests used as part of the mass #covid-19 testing
programme, despite concerns raised by the US regulator over the main test—the #Innova SARS-CoV-2 antigen rapid qualitative test.
Last week the US Food and Drug Agency (FDA) warned the public to stop using the #Innova test for #detecting infection
& suggested that any unused #tests should be #destroyed, binned, or returned
The agency published a class 1 recall—the most serious kind—of the test after an investigation uncovered “significant concerns that the performance of the #test has not been adequately #established,
Read 10 tweets
As a household that works in the #NHS and #schools, this "compare and contrast" of #LateralFlowTest kits might be useful in the light of the #FDA ruling on #Innova tests ... 1/5
Different colour branding but: same manufacturer in Xiamen, same distributor in West Drayton, same tubes, same style lot numbers ... so safe to conclude, same product?! 2/5
But crucial difference over accompanying leaflets. #Innova branded one (only) clearly states "negative results do not rule out infection and should not be used as the sole basis for infection control decisions" - but that's exactly what has been happening e.g. in #schools 3/5
Read 5 tweets

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